Identity
- Trade Name
- Susol® Blacks File SE Coarse 14cm FDA UDI
- Generic Name
- Toenail file/rasp, single-use FDA UDI
- Model / Reference
- SS08-0553 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060418834005 FDA UDI
- FDA Product Code
- GAC FDA UDI
- GMDN Term
- Toenail file/rasp, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Toenail file/rasp, single-use
Susol® Blacks File SE Coarse 14cm by Bailey Instruments Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bailey Instruments Ltd
Sources (2)
- FDA UDI 4c8a0884-31f6-4825-98a0-5f27c57f245d 32 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 22, 2026